The United States Patent and Trademark Office has issued US Patent No. 10682414, titled, “Intranasal epinephrine formulations and methods for the treatment of disease,” to ARS Pharmaceuticals, the company said. The patent covers the use of low dose (0.1 to 2.4 mg) intranasal epinephrine for for the treatment of anaphylaxis.
The patent covers any low-dose epinephrine nasal spray formulation that includes any absorption enhancer, not just ARS’s ARS-1 nasal spray which contains Intravail absorption enhancer. A previously issued composition of matter patent (Patent No. 10,576,156) covers ARS-1.
ARS-1, which received Fast Track designation from the FDA in February 2019, delivers a 1 mg dose of epinephrine. That dose of the intranasal formulation has been shown to be bioequivalent to a 0.3 mg dose of injected epinephrine.
ARS Pharmaceuticals President and CEO Richard Lowenthal commented, “This new patent is very significant in progressing our efforts to provide caregivers and patients who suffer from severe allergic reactions a more convenient, less threatening and more reliable method to dose epinephrine quickly. This new Track One patent is one of three primary claims in our international patents filed for ARS-1 to support our worldwide partnering efforts. Epinephrine autoinjectors can be seen as scary, painful and bulky to carry. ARS-1 is small, delivered by a very reliable device, and achieves injection like absorption without a needle, which removes the fear and apprehension of using a needle. The ability to achieve rapid absorption and bioequivalent exposure with only a single 1 mg dose is critical to the safety and efficacy of the product. Once approved, we anticipate that ARS-1 will be a reliable, easily administered needle-free treatment to address emergency allergic reactions, and the novelty of the ARS-1 technology has been validated by the issuance of these two patents.”
Read the ARS Pharmaceuticals press release.
